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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S ESOPHAGEAL COVERED STENT; ESOPHAGEAL STENT
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TAEWOONG MEDICAL CO.,LTD. NITI-S ESOPHAGEAL COVERED STENT; ESOPHAGEAL STENT Back to Search Results
Model Number EK2410FNT2
Device Problem Material Perforation (2205)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2024
Event Type  malfunction  
Event Description
During stent deployment, the physician found that the ptef membrane is uneven and has some holes which may cause tissue-in-growth and substance to contact the fistula.Due to quality concern, the physician decided to remove this stent and use another stent to complete the surgery.
 
Manufacturer Narrative
It was reported that during stent deployment, the physician found that the ptef membrane is uneven and has some holes.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Based on the attached photo, it was confirmed that the surface of the ptfe cover looked uneven and holes were observed.However, it is hard to exactly analyze because the device was not returned yet.Investigation will be conducted once device is returned and we will send follow-up report accordingly.
 
Manufacturer Narrative
It was reported that during stent deployment, the physician found that the ptef membrane is uneven and has some holes.As a result of analysis of returned device, only the stent was returned.Holes were observed in the ptfe cover of the stent.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Based on the attached photo, it was confirmed that the surface of the ptfe cover looked uneven and holes were observed.Inspection of hole on the stent cover is performed by taewoong medical during stent coating process and half-finished product inspection process.Based on the observed holes in the ptfe cover of the stent, there is a possibility the hole and damage might have occurred during the procedure.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.Through the user manual by taewoong, it is stated that "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: cover breakdown with ingrowth of the mucosa".This suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.
 
Event Description
During stent deployment, the physician found that the ptef membrane is uneven and has some holes which may cause tissue-in-growth and substance to contact the fistula.Due to quality concern, the physician decided to remove this stent and use another stent to complete the surgery.
 
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Brand Name
NITI-S ESOPHAGEAL COVERED STENT
Type of Device
ESOPHAGEAL STENT
Manufacturer (Section D)
TAEWOONG MEDICAL CO.,LTD.
14, gojeong-ro
wolgot-myeon
gimpo-si, gyeonggi-do 10022
KS  10022
Manufacturer (Section G)
TAEWOONG MEDICAL CO.,LTD.
14, gojeong-ro
wolgot-myeon
gimpo-si, gyeonggi-do 10022
KS   10022
Manufacturer Contact
lee
14, gojeong-ro
wolgot-myeon
gimpo-si, gyeonggi-do 10022
MDR Report Key18794969
MDR Text Key336402042
Report Number3003902943-2024-00008
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEK2410FNT2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received02/07/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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